Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain†.
Bryce Rowland, Kelly S Barth, Kevin M Bell, Amber K Brooks, Andrea L Chadwick, Annika Cleven, Robert W Hurley, Sean Mackey, Kushang V Patel, Sara R Piva, Michael J Schneider, Fatima Al-Kadhi, Bernice Asante-Nketiah, Sarah Bagaason, Anna Batorsky, Jeffrey J Borckardt, Anton E Bowden, Timothy S Carey, Joel Castellanos, Lucy Chen, Brooke Chidgey, Diane Dalton, Jonathan S Dufour, Jaclyn L Eberting, Seth M Eller, Aaron J Fields, Julie M Fritz, Amber Fu, Inam Ghulamhussain, Rachel West Goolsby, Carol M Greco, Sarah Grim, Cameron A Gunn, Lindsay Hanes, Richard E Harris, Steven E Harte, Afton L Hassett, Kinsey Helton, Anna Hoffmeyer, Anastasia Ivanova, Sara Jones Berkeley, Chelsea Kaplan, Kelley M Kidwell, Gregory G Knapik, Michael R Kosorok, Gregorij Kurillo, David Li, Remy Lobo, Joseph Long, Jeffrey C Lotz, Prasath Mageswaran, Sharmila Majumdar, Jianren Mao, William S Marras, Lance M McCracken, Micah McCumber, Samuel A McLean, Miranda McMillan, Wolf Mehling, Rafael Mendoza, Ulrike H Mitchell, Vitaly Napadow, Conor O'Neill, Sydnee Pearson, Scott Peltier, Sean D Rundell, Sonja Ryser, Andrew Schrepf, Emily Schulze, John Sperger, Nam Vo, Mark S Wallace, Abigail M Wampler, Ajay D Wasan, Tristan E Weaver, Kenneth A Weber, Lauren Wilcox, David A Williams, Leslie Wilson, Jacqueline E Woo, Fadel Zeidan, Beibo Zhao, Brianna Zhou, Kevin J Anstrom, Daniel J Clauw, Gwendolyn A Sowa, Matthew C Mauck
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引用次数: 0
Abstract
Objective: Chronic low back pain (cLBP) is a significant public health problem in the United States. A method to identify treatments that are most likely effective for an individual patient based on their unique characteristics is needed.
Methods: The Biomarkers for Evaluating Spine Treatments (BEST) Trial is a sequential, multiple assignment, randomized trial designed to estimate an optimal treatment or combination of treatments to reduce pain intensity and interference at 24 weeks in individuals with cLBP.
Results: We describe the patient-reported characteristics of the BEST Trial at the Baseline visit. Data collection for extensive required phenotyping is reported. We analyzed the run-in period of the BEST Trial to evaluate predictors of run-in failure. The BEST Trial enrolled 1019 participants and randomized 805 participants (61.6% female, mean age 50.4, 12.5% Black or African American) to the first stage of treatment. We collected extensive required phenotyping on all 805 randomized BEST Trial participants, and additional optional phenotyping on 510 (63.4%) participants.
Conclusions: The BEST Trial successfully enrolled a racially and geographically diverse sample of chronic low back pain patients and completed rich phenotypic assessments to inform our primary goal of identifying in whom different treatments show optimal response. We demonstrated the feasibility of collecting extensive phenotypic assessments in a multi-site clinical trial of cLBP.
Clinical trial registration number: The Biomarkers for Evaluating Spine Treatments (BEST) Trial is registered on ClinicalTrials.gov. Registration number: NCT05396014 (https://clinicaltrials.gov/study/NCT05396014).
期刊介绍：
Pain Medicine is a multi-disciplinary journal dedicated to pain clinicians, educators and researchers with an interest in pain from various medical specialties such as pain medicine, anaesthesiology, family practice, internal medicine, neurology, neurological surgery, orthopaedic spine surgery, psychiatry, and rehabilitation medicine as well as related health disciplines such as psychology, neuroscience, nursing, nurse practitioner, physical therapy, and integrative health.
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